- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00430131
Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches
This project (CO-OP II) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (CP). The initial study was comprised of a series of four single case studies with children with CP. It evaluated the potential of the Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children with CP and tested the procedures for CO-OP II. The overall objective of the full series of studies is to determine whether better functional outcomes are achieved for children with CP with CO-OP intervention than with contemporary occupational therapy treatment.
The primary objective of CO-OP II is to establish the feasibility of conducting a full scale randomize control trial (RCT) to discover if there are differences in functional outcomes (i.e., improvement in task performance, self efficacy) between a group of children with CP receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In order to meet this objective, a pilot RCT will be conducted to answer the specific research questions outlined below:
- Do children wiht CP acquire the skills they set as goals in each of the two treatment groups?
- Do the acquired skills generalize and transfer?
- Are the skills maintained at 4 months post intervention?
- Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy than the CTA?
- Does amount of parent involvement have any effect on skill acquisition or self efficacy?
Completion of this pilot RCT will provide the necessary data to conduct a full study to test the following hypothesis:
- Children with CP who receive CO-OP treatment will be more successful than children receiving CTA in improving their performance on child-chosen skills and they self efficacy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- between 7 and 12 years of age
- diagnosis of cerebral palsy with hemiplegia or spastic diplegia
- Level 1,2 or 3 on the Gross Motor Function Classification Scale(GMFCS)
- normal intelligence (IQ> 85 on at least one scale (verbal or performance) of the Kaufman Brief Intelligence Test (KBIT-2)
- child assent and agreement to participate
- parental consent and agreement to participate
- sufficient language ability to communicate with and be understood during treatment
Exclusion Criteria:
- previously received or presently receiving a cognitive treatment for motor-based performance problems
- use of alternative communication system such as PECS or communication board
- regular use of BOTOX during intervention period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Debra L Cameron, PhD. O.T., University of Toronto
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BKR-06-055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
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Hadassah Medical OrganizationCompleted
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